Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01262365) enrolled 793 adults with lupus across three groups: 266 received a placebo (inactive treatment given as weekly infusions), 262 received epratuzumab at a dose of 1,200 mg every other week, and 265 received epratuzumab at 600 mg per week. The trial was measuring how many participants met a combined set of response criteria — based on disease activity scores rated by doctors, and whether participants' other medications remained stable — at several points over 48 weeks. The reported data shows that at the main measurement point of 48 weeks, 34.1% of participants in the placebo group met the combined response criteria, compared with 39.8% in the 1,200 mg every-other-week group and 37.5% in the 600 mg per week group. At earlier time points, the reported figures were: at 12 weeks — 31.3% (placebo), 42.2% (1,200 mg), and 39.9% (600 mg); at 24 weeks — 33.7% (placebo), 43.0% (1,200 mg), and 39.1% (600 mg); and at 36 weeks — 33.3% (placebo), 41.8% (1,200 mg), and 35.1% (600 mg). The trial also tracked whether participants' daily steroid (corticosteroid) doses changed over time, with results reported across several categories, though a full breakdown of those categories was not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 29381843) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Lupus Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Your blood test at the screening visit shows a positive result for antinuclear antibodies (ANA), which are markers found in certain autoimmune conditions
- You have been formally diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) and meet at least 4 out of 11 recognised diagnostic criteria set by the American College of Rheumatology
- Your lupus is currently moderately to severely active, as measured by a specific lupus activity scoring tool called the BILAG Index
- Your lupus is currently moderately to severely active, as also measured by another scoring tool called the SLEDAI
- You are already on a stable lupus treatment plan that includes steroid medication AND either an immune-suppressing drug or an antimalarial drug
Who may not be able to join:
- You are currently breastfeeding, pregnant, or planning to become pregnant
- Your lupus is severely affecting your kidneys
- Your lupus is severely affecting your brain or mental health (confirm with trial site)
- You have a condition or situation that already weakens your immune system
- Your doctor believes you are at a particularly high risk of getting a serious infection
- You have a history of cancer, unless it was cervical carcinoma in situ, basal cell carcinoma, or a certain type of skin cancer that has been treated
- You have received any live vaccine in the 8 weeks before your screening visit
- You have a history of infections, including hepatitis B or C
- You have a history of substance misuse or dependence, or another serious ongoing health condition (confirm with trial site)
- You have had a blood clot or related event within the past year before screening
- You have significant abnormalities in your blood counts or blood cells (confirm with trial site)
- You have received certain other B-cell targeted antibody treatments within the past 12 months
- You have taken blood-thinning medication (not including anti-inflammatory painkillers like ibuprofen) within the 12 weeks before screening
- You have taken part in this study before, or have previously been treated with the drug being studied (epratuzumab)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: UCb Clinical Trial Call Center, +1 877 822 9493 (UCB)
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.